| (a) Application. (1) A complete narcotic drug treatment application provided by the department must be submitted to the State Methadone Authority (SMA) to apply for an approved narcotic drug permit to operate a narcotic treatment program (NTP). (2) A complete application filed in accordance with this subsection for an NTP will be reviewed and evaluated by the department, in accordance with §229.281 of this title (relating to Processing Permit Application Relating to Food and Drug Operation). An application shall not be considered complete until an application for an NTP has been submitted to the Drug Enforcement Administration (DEA), and to the Substance Abuse and Mental Health Services Administration (SAMHSA). If the program application is denied by the department, the applicant shall have an opportunity for a hearing pursuant to §229.147 of this title (relating to Denial of Application; Suspension or Revocation of Narcotic Drug Permit). (3) A person acquiring an NTP currently operating under department approval must submit a new application in accordance with this subsection and an initial fee as required in subsection (b)(1) of this section. A narcotic drug permit will be issued to a new owner or new location and the permit issued to the previous owner or location shall be void and surrendered to the department by certified or registered mail within 24 hours following receipt of the new approved narcotic drug permit. (4) Individuals who are currently chemical dependent and/or have a history of chemical dependency on any substances that are subjected to abuse within two years of application for a permit, are not eligible for ownership of an NTP. (5) The number of patients that a clinic is approved to treat is in direct proportion to the number of counselors employed by that clinic. This proportion is a maximum of 50 patients for each counselor. The NTP may exceed the counselor to patient ratio on a temporary basis to permit hiring of new staff when new admissions cause a ratio imbalance or when current staff leave and must be replaced. (6) Applicants must provide to the department complete information for evaluation of criteria concerning location, funding, compliance history, and competency to operate an NTP. (A) Scope. The department intends that new NTP locations be established to serve diverse patient populations without singular regard to proximity of location to an existing program(s). The department has established criteria to prevent competition for patients among NTPs in the same area that may result in increased noncompliance with state and federal regulations and compromised patient care. (B) Criteria. An applicant must affirmatively demonstrate the following: (i) serviceability of the program at the proposed location by providing the department the following: (I) a map showing proximity of the proposed NTP to existing programs within a three-mile radius; (II) a description of how the new program will ensure it will provide treatment services for an underserved population and not duplicate treatment services for existing patients in treatment at an established program in the area; (III) copies of planned promotional materials, advertisements, and other techniques to publicize the proposed program; and (IV) procedures that will be used to identify whether a patient is enrolled in another clinic; (ii) the source and adequacy of financial assets necessary to operate the program; (iii) if applicable, the compliance history of the applicant, which includes any issues reported to the department by SAMHSA, DEA or any other regulatory agency; (iv) adequate planning and organizational structure demonstrated by full and complete answers submitted to all questions in the application materials; and (v) a statement that the applicant has read, understood and agreed to follow all federal and state regulations concerning operation of an NTP. (b) Fees and fee assessments. (1) Initial fees. All applicants for an NTP permit must submit an initial application fee of $1,000 with each application. All initial fees are nonrefundable. An application will not be processed unless it is submitted with the initial fees. (2) Patient fees. A permit holder must submit a patient fee for each patient the NTP is approved to treat. The patient fee must be paid no later than 30 days from the date the permit is issued. A nonrefundable initial fee of $150 must be submitted for each medication unit requested in the initial application. The NTP or medication unit will be issued a patient fee certificate for a two-year term. The patient fee is $60 per patient. (3) A current or renewal patient fee certificate is transferable until the expiration date on the certificate if the following conditions are met: (A) the permit holder relocates with no change of name of the permit holder; or (B) a new permit holder takes over operation of an existing NTP at the existing location with no interruption of patient treatment operations. (4) Renewal permit fees. A permit holder must submit a renewal application form, a current status report, and renewal fees prior to the expiration date of the current patient fee certificate. A renewal permit shall only be issued when all past due fees and delinquency fees are paid. (A) A permit holder who submits a renewal application and fees after the expiration date must pay delinquency fees of $5 for each patient the NTP is approved to treat. (B) A permit holder who submits a current status report after the expiration date must pay a delinquency fee of $350. (C) Renewal patient fee certificates are issued for two-year terms. The renewal fee is nonrefundable and is $60 per patient. (D) Increase in patient certificates. A permit holder who requests an increase in the number of patients the NTP is approved to treat prior to the expiration of a current patient certificate must provide documentation demonstrating adequate facility and staff capacity to accommodate an increase. Temporary transfer patients should not be included. The patient fee is $60 for each additional patient. (c) Permit. (1) All NTPs, persons, or organizations are required by the Health and Safety Code, Chapter 466, to obtain an approved narcotic drug permit in order to provide treatment to patients with a primary diagnosis of an opiate addiction. (2) An approved narcotic drug permit shall be issued by the department subsequent to federal and state approval of an application as required in subsection (a) of this section, and payment of a fee as required in subsection (b)(1) of this section which will provide authorization to operate an NTP. (3) Failure to pay the appropriate fee as required in subsection (b) of this section is grounds for suspension, revocation, or denial of a permit as provided in §229.147 of this title (relating to Denial of Application; Suspension or Revocation of a Narcotic Drug Permit). (4) A permit issued by the department for the operation of an NTP is valid only for the location of the NTP stated on the permit. A permit issued by the department is not transferable from one facility to another facility and must be surrendered to the department if the person holding the permit sells or otherwise conveys the facility to another person. If the permit holder sells or otherwise conveys the facility to another person or changes the location of the facility, a new application must be submitted as required in subsection (a) of this section and the fees must be paid as required in subsection (b) of this section. The previous permit must be surrendered to the department as specified in subsection (a)(3) of this section. (5) A permit holder requesting to move an NTP to another location must submit a new application for a new permit as required in subsection (a) of this section, and pay the initial fee in accordance with subsection (b)(1) of this section. The previous permit must be surrendered to the department as specified in subsection (a)(3) of this section. (6) An approved narcotic drug permit issued by the department shall remain in effect until suspended or revoked by the department or surrendered by the permit holder. (7) The approved narcotic drug permit and the current certificate must be posted in a conspicuous location within the premises of the NTP. (8) Methadone, or any other drug approved by the FDA for the treatment of opiate addiction, are the only drugs which shall be used in NTPs for patients with opiate addiction. (d) Texas Online. Applicants may submit initial and renewal permit applications under these sections electronically by the Internet through Texas Online at www.texasonline.state.tx.us. The department is authorized to collect fees, in amounts determined by the Texas Online Authority to recover costs associated with application and renewal application processing through Texas Online. |
| Source Note: The provisions of this §229.145 adopted to be effective September 3, 1990, 15 TexReg 4823; amended to be effective September 1, 1992, 17 TexReg 5545; amended to be effective August 28, 1996, 21 TexReg 7845; amended to be effective December 31, 2001, 26 TexReg 10871; amended to be effective January 1, 2005, 29 TexReg 11980; amended to be effective February 1, 2006, 31 TexReg 501 |
